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Humacyte Strengthens Intellectual Property Portfolio with Issuance of New U.S. Patent Covering Symvess and Other Bioengineered Tissues

The new protection complements existing patents and applications covering product design, composition and manufacturing methods.

(Moderate)

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Humacyte (Nasdaq: HUMA) received a new U.S. patent covering aspects of Symvess manufacturing, sterilization, storage and shipping, with protection into 2043.

U.S. Patent No. 12,742,144 also covers other bioengineered human tissues and complements existing patents and applications covering product design, composition and manufacturing methods. Symvess is an acellular tissue engineered vessel, a bioengineered blood vessel, that received FDA approval for extremity vascular trauma in December 2024. Humacyte plans to submit a supplemental biologics license application in 2026 seeking to add dialysis access as a second approved indication.

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Positive

  • Minor pointU.S. Patent No. 12,742,144 provides protection into 2043 for Symvess and other bioengineered tissue processes.
  • Minor point. Forward-looking: it has not happened yet and may not happen.Dialysis access application is planned for 2026, seeking a second approved indication for the ATEV.

Negative

  • None.
Argus 15 min delay 6 alerts
+3.11% vs previous close $0.46 last price 0.5x rel. volume Open Argus
Details

Market move: HUMA +3.11% vs previous close. Symvess patent issuance

$0.43 – $0.48 Day Range
$127.84M Mkt Cap at Last Price

On Oct 28, the day this news came out, the latest delayed price for HUMA is 3.11% above the previous close. Our momentum scanner has recorded 6 alerts for this stock so far that day. The latest delayed price is $0.46.

Data tracked by StockTitan Argus (15 min delayed). Upgrade to Gold for real-time data.

Key Figures

Patent protection term: Into 2043
Patent protection term
Into 2043
Coverage for aspects of manufacturing, sterilization, storage and shipping

Key Terms

supplemental bla, biologics license application, rmat designation, fast track designation
4 terms
supplemental bla regulatory
"plans to submit a supplemental BLA this year seeking to add dialysis access"
A supplemental BLA is an application to the U.S. regulator asking permission to change an already approved biologic medicine — for example to add a new use, alter dosing, change how it’s made, or update labeling. Investors watch these filings because approval can unlock new sales or lower costs (like adding a popular new feature to an existing product), while denial or delays can limit growth and affect a company’s revenue outlook.
biologics license application regulatory
"Humacyte’s Biologics License Application for the acellular tissue engineered vessel"
A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.
rmat designation regulatory
"receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation"
A Regenerative Medicine Advanced Therapy (RMAT) designation is a US regulatory status granted by the Food and Drug Administration to experimental cell, gene or tissue-based therapies that treat serious conditions. It gives the developer extra access to regulators and opportunities for faster review, similar to getting a fast-track lane at a government agency; for investors, RMAT can shorten time to market and reduce regulatory risk, which may increase a program’s commercial value and stock impact.
fast track designation regulatory
"has also received FDA Fast Track designation"
Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.

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– Patent provides coverage into 2043 for key aspects of how Symvess is manufactured, sterilized, stored and shipped.

DURHAM, N.C., Oct. 28, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced the issuance of a new U.S. patent covering key aspects of the manufacturing, sterilization, storage and shipping of Symvess® (the acellular tissue engineered vessel, or ATEV) and other bioengineered human tissues. U.S. Patent No. 12,742,144, titled “Systems, Devices and Methods for Engineered Tissue Construct Transport and Containment” provides protection into 2043 and complements a family of existing patents and patent applications encompassing the design and composition of Humacyte’s products and their methods of manufacture.

“The issuance of this patent significantly strengthens our intellectual property portfolio by extending protection for key aspects of our bioengineering platform into 2043,” said Laura Niklason, Founder, President and Chief Executive Officer of Humacyte. “The extended term of this new patent provides long-term protection for key aspects of our technology and enhances our ability to create sustainable value as we aim to advance our next-generation regenerative medicine products toward broader clinical and commercial adoption.”

Humacyte’s lead product, Symvess, is a first-in-class bioengineered human tissue designed to serve as a universally implantable vascular conduit for use in arterial replacement and repair. Humacyte plans to submit a supplemental BLA this year seeking to add dialysis access as the second approved indication for the ATEV following its December 2024 FDA approval in the vascular trauma indication. Symvess is grown using human cells and produced in a bioreactor bag that houses the blood vessel throughout manufacturing, sterilization, storage and shipment, remaining sealed until it is opened in a surgical theater for implantation into a patient. The newly issued patent covers methods of producing, serializing, storing and shipping the bioreactor and the ATEV housed inside. The ATEV is produced in proprietary manufacturing systems, including Humacyte’s LUNA200™ production equipment, which are covered by multiple issued U.S. and international patents and patent applications. The Company has an 83,000 square foot bioprocessing facility, with the ability to manufacture human tissue of different diameters and lengths at commercial scale located in Durham, North Carolina.

For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

About Humacyte
Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s Biologics License Application for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication was approved by the FDA in December 2024. ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease (PAD). Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com.

Forward-Looking Statements
This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, our plans and ability to commercialize Symvess and, if approved by regulatory authorities, our product candidates, successfully and on our anticipated timelines; our ability to manufacture Symvess and, if approved by regulatory authorities, our product candidates in sufficient quantities to satisfy our clinical trial and commercial needs; the anticipated benefits of our ATEVs relative to existing alternatives; the anticipated commercialization of our ATEVs and our ability to manufacture at commercial scale; our plans and ability to execute product development, process development and preclinical development efforts successfully and on our anticipated timelines; the anticipated characteristics and performance of our ATEVs and the public perception thereof; the implementation of our business model and strategic plans for our business; and the timing or likelihood of regulatory filings, acceptances and approvals. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, competitive and/or reputational factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025 and Form 10-Q for the quarter ended June 30, 2026, each filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.

Humacyte Investor Contact:
Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602
jallaire@lifesciadvisors.com
investors@humacyte.com

Humacyte Media Contact:
Rich Luchette
Precision Strategies
+1-202-845-3924
rich@precisionstrategies.com
media@humacyte.com


FAQ

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What does Humacyte’s new Symvess patent cover, and how long does protection last?

U.S. Patent No. 12,742,144 covers aspects of manufacturing, sterilization, storage and shipping of Symvess and other bioengineered human tissues, with protection into 2043. It complements existing patents and patent applications covering product design, composition and manufacturing methods.

When does Humacyte plan to seek FDA approval for ATEV dialysis access?

Humacyte plans to submit a supplemental biologics license application in 2026 seeking dialysis access as the ATEV’s second approved indication. The existing FDA approval, granted in December 2024, covers extremity vascular trauma.

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